Diane Ashton, Fox News: April 11, 2019.

Thousands of women across the country who believe their breast implants are making them sick are calling on the Food and Drug Administration to take action. The women blame their implants for a number of auto immune illnesses, and a variety of symptoms such as joint and muscle pain, chronic fatigue and migraines. They’re demanding new warnings and restrictions on the devices.

The FDA maintains there is not enough evidence to link breast implants and connective tissue diseases like lupus and rheumatoid arthritis. However, it has acknowledged that women with breast implants may have an increased risk of developing a rare cancer called anaplastic large cell lymphoma (ALCL). Nearly 700 cases have been reported worldwide, and most involved textured implants. Canada and the Netherlands are suspending sales of textured implants, and France has banned them.

An FDA advisory committee held hearings on breast implant safety on March 25 and 26 in Silver Spring, Maryland. After the two-day hearing, the panel didn’t recommend any immediate restrictions on the implants. The FDA says it will reveal what actions it will take in the coming weeks.

Dr. Diana Zuckerman, president of a Washington DC-based non-profit called the National Center for Health Research, testified at the March 25th FDA hearing. She tells Fox News, “We don’t know how many women get sick from breast implants but we do know that some women are getting very sick. And the evidence is when the implants are removed, they can have almost miraculous recoveries. And so it’s time for the FDA to acknowledge that breast implants can make women sick with these autoimmune types of symptoms. And to warn them about it before they get breast implants, but also to warn them about it when they start to get sick.”

At the FDA hearing, researchers said it’s possible that silicone that leaks from implants can trigger or worsen immune system disorders in some patients. “One of the things that’s possible is that some women have a genetic predisposition to have a problem with breast implants,” Zuckerman says. “Maybe they have a family member with auto immune disease or maybe they themselves have had some auto immune symptoms. That’s what we found in our study, so we think that probably some women are more likely to get sick than others. “

Breast implant makers and the American Society of Plastic Surgeons say the implants are safe. But dozens of women who attended the FDA hearing, including Andrea Ottaiano of Morristown, New Jersey, are calling for a “black box” warning on the devices and a ban on textured implants. They also want a better patient consent process so women can be informed of the risks before getting breast implants.

“There’s not a lot of full disclosure that goes along with these devices and a lot of women that were getting them whether it was for augmentation or it’s a breast cancer reconstruction aren’t fully presented with the risk-benefit ratio, “ Ottaiano says. “And that… was just quite shocking to me, because in the field that I worked in for years, it was always so important to have transparency, and present if there were safety issues or risks.”

Ottaiano, a three-time cancer survivor, is getting her implants removed this spring. She says in the last several years, she has suffered from a painful complication called capsular contracture, along with joint pain, fatigue and other symptoms she believes are being caused by her breast implants. “My concern for my own health is I’ve had implants in for 11 years post a breast cancer bilateral mastectomy, and I’ve done the research and done the math that they are not lifelong devices. They do have a life expectancy and sometimes they need to come out. So I was lucky enough to find a doctor last year that actually listened and agreed to a course of action.”

In the United States, about 400,000 women get breast implants each year. Some 100,000 get them after cancer surgery. New York City plastic surgeon Dr. Constance Chen says she tries to educate her patients about the pros and cons of breast implants, and tell them about alternatives, such as breast reconstruction using natural tissue. Dr. Chen thinks more research needs to be done into breast implant related illnesses.  “It’s very difficult to prove causality when it comes to auto immune illnesses and implants,” Chen says. “So the evidence is sometimes hard to get which I think is part of the problem.”

She adds, “There are a lot of people who find implants just don’t agree with them, whether it’s they develop these auto immune symptoms, or it’s a foreign body that their body just doesn’t want inside of them. I’ve seen too many people who have developed these non-specific symptoms — like brain fog, fatigue, joint pains, food allergies, drug allergies, etcetera — to write them off.”

See the original article here.

Ayanna Alexander, Bloomberg Law: April 8, 2019.

Insurers can deny coverage for treatment related to infections caused by breast implants, causing a budding advocacy movement.

“The insurers use the fact that there’s no true medical definition for breast implant illness as an opportunity to try not to pay for it,” said Scot Glasberg, a former president of the American Society of Plastic Surgeons.

Women who have suffered from breast implant illness are asking the FDA for help, but the agency can’t do much when it comes to insurance coverage. Leaking implants can cause a variety of illnesses, but women who need them removed face a series of obstacles from getting necessary screenings to negotiating with insurers to cover the procedures.

The FDA has taken an interest in the problem, however. It held a public meeting on the issue in March. It also flagged two implant manufacturers—Sientra Inc. and Mentor Worldwide LLC—for failing to test their products for safety and effectiveness after they were approved.

Unless breast implants leak, interrupt cancer screenings, or lead to chronic severe pain in the breasts, insurers won’t deem removal medically necessary, according to Diana Zuckerman, who heads the National Center for Health Research. “Since breast implant illness isn’t recognized, it’s not included,” she said in an interview.

Major health insurance providers such as Aetna Inc., cover some breast implant removal surgeries, but they have to be medically necessary, not cosmetic. Aetna also considers the removal medically necessary if the patient has a cancer of the immune system.

The average cost for breast implant removal surgery ranged from $5,000 to $8,000 in 2017 for uninsured patients, according to the National Center for Health Research. The average surgeon’s fee for the procedure was $2,556 in 2018, according to the American Society of Plastic Surgeons. That didn’t include anesthesia, operating room facilities, or other related expenses.

Jamee Cook, the co-founder of the Breast Implant Victim Advocacy, said it’s also difficult to get coverage for the test to determine if the implant did actually rupture.

“What we’re seeing is some insurances will cover if it’s a confirmed rupture,” she said. “The problem is not all can be confirmed. Another problem is if the implant surgery was cosmetic, most of insurers won’t cover the MRI to see if it did rupture.”

Cook had a ruptured breast implant in 2012, which caused swollen lymph nodes, fatigue, and chronic sinus infections. She ended up with an autoimmune illness and couldn’t get her implant removed until 2015.

Autoimmune illnesses or infections that come from breast implants can affect lymph nodes, lungs, saliva, and tear glands and joints. Silent ruptures, which normally occur in silicone-filled implants, are tears that leave little to no signs or symptoms because the silicone is usually trapped in the tissue that surrounds it.

Zuckerman said it’s easier to get removal or other treatment covered by insurance if plastic surgeons vouch for their patients and note the symptoms for insurers. That doesn’t always happen during consultations.

“Of, course, doctors can’t tell insurers what to cover, but a statement can say they know that women are suffering and help patients get closer to coverage,” she said

Individually, some plastic surgeons have been willing to work with insurance companies to help patients get covered. But as a whole, she said the industry has been reluctant to push to have breast implant illness recognized as a medical condition.

In his own practice, Glasberg said he notes the best code that describes the illness as it relates to implants and adds it to a bill, but the insurance company usually sends it back.

“In order to [appeal], I have to get documents from whoever the patient has been seeing to prove they’ve been dealing with [breast implant illness] symptoms,” he said. “If these other doctors can weigh in and say it could be related to the implants, that helps.”

Coverage is determined based on the patient’s medical need and circumstances for treatment, the provider and specific plan, who’s providing the treatment and where, and other medical factors according to Cathryn Donaldson, a spokeswoman for America’s Health Insurance Plans, a trade group representing insurers.

“If it is medically necessary, it is generally covered,” Donaldson said. “I would recommend patients reach out to their insurance provider if they have questions about specific benefits and/or their provider network.”

Zuckerman said women can build a better case to avoid insurance denial.

“We found that women were only asking about the symptoms associated with [breast implant illness] because that was more severe to them, even though they had leaking implants or pain,” she said. “They have to focus on and talk about what insurance companies care about covering.”

Glasberg said an FDA study on women suffering from breast implant illness will help medically define it and could even help insurers see the medical need for treatment.

“The FDA basically is in the business of studying patient safety, so that’s probably the only direction they can go,” he said. “There are many symptoms.”

He said plastic surgeons could also be a resource in tightening the “loosely defined” symptom list and “come up with a diagnosis code.” […]

See original story here.

Johane van den Berg, Longevity: April 5, 2019.

As of Thursday, specific types of breast implants – namely those with a textured or polyurethane coating – are no longer allowed in France. The ban of these implants are due to concerns that they have the potential to cause a type of cancer called anaplastic large cell lymphoma (BIA-ALCL). In finalizing the ban, France has become the first country ever to do so. According to Eyewitness News, the National Agency for Medicines and Health Products (ANSM) called the ban a “precautionary measure” which was taken due to the “rare but serious danger” caused by the implants.

It is estimated that approximately 70 000 French women currently have the banned implants, but it is not recommended that they have “explant” surgery to have them removed. Out of an estimated 500 000 women who have undergone breast augmentation that includes different types of breast implants, 59 cases of ALCL have been reported. As of yet, three women have died from cancer. However, the ANSM said in a statement that they had not identified “any immediate risk to the health of women carrying the implants concerned.” As reported by Euronews, after the ANSM consulted with experts, they came to the conclusion that the more “textured and rough” the implants, the greater the risk of developing the disease.

In addition, earlier this year, the most popular breast implants from the pharmaceutical company, Allergan, was withdrawn from the market in Europe, while December 2018 saw ANSM in France ordering the company to cease manufacturing and selling its Microcell and Miocell implants. Both of these types of breast implants are textured. With this week’s ban in France, Allergan’s Biocell implants will also be removed. In addition to Allergan, five more implant manufacturers will be affected by this ban, including Arion, Sebbin, Nagor, Eurosilicone, and Polytech.

It is not breast cancer. When presenting with breast implants, this cancer of the immune system (Hodgkin’s lymphoma) is typically found inside a capsule of fibrous scar tissue instead of inside the surrounding breast tissue. Research indicates that they are found more frequently in textured breast implants than smooth implants. As of yet, the type of filling does not seem to have an influence on this. It develops when white blood cells, known as T-cells, become abnormal in nature. They are typically present in the lymph nodes but have been known to affect other areas of the body. Click here to find out the reports from Harvard Health on this cancer relating to breast implants.

In addition, the agency communicated on this issue as early as 2011. According to Binita Ashar, MD, general surgeon and the director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, the FDA was the first public agency to warn the public about the risks for women with breast implants to develop this disease. In a press announcement that was released in February this year, results from an updated analysis of BIA-ALCL indicate that in the US, 457 women have been affected by this cancer, with the first documented case reported in 1997. 9 related deaths have been recorded.

The guidelines of the National Comprehensive Cancer Center (NCCN) that covers the diagnosis and treatment of BIA-ALCL state that the majority of women with this disease present with “a large spontaneous perioprosthetic fluid collection occuring at least 1 year and on average 7-10 years following cosmetic or reconstructive implantation following cosmetic or reconstructive implantation with a textured surface implant.”

The same guidelines have indicated that early diagnosis and treatment of the disease is usually associated with “excellent prognosis”. Metastasis has, however, been reported. In addition, the importance of initial ultrasound evaluation of women presenting with signs and symptoms of BIA-ALCL has been emphasized, and the NCCN recommends fine-needle aspiration as the method of fluid sampling.

“We hope that this information prompts providers and patients to have important and informed conversations about breast implants and the risk of BIA-ALCL. “At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,”. Dr Ashar wrote.

When it comes to patients, the FDA recommends that each person take the responsibility to educate themselves before agreeing to surgery. “Before getting breast implants,” the agency said in a statement, “make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surface implants. Additional information is available on the FDA’s Breast Implants website.

After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedures for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women. It ranks above liposuction, nose reshaping, eyelid surgery and a tummy tuck. The problem, explains Dr. Diana Zuckerman, Ph.D., and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation.

Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.

See the original article here.

Kris Pickel, CBS5 News: March 25, 2019.

Are breast implants safe?

Tens of thousands of women say breast implants made them sick.

The US Food and Drug Administration (FDA) is now looking into the claims that Arizona’s Family Kris Pickel has been investigating for years.

Women from all over the country went to FDA headquarters in Washington on Monday.

These women represent the growing number of women coming forward  who believe breast implants are the source of unexplained illnesses ranging from extreme fatigue, joint pain to memory issues and auto-immune disorders.

Breast Implant Illness is not currently recognized as a medical condition.

The FDA’s stance is that science doesn’t link implants to illness. An FDA panel is taking another look at the science.  They are also hearing from doctors, experts, industry representatives and  women who became ill after getting implants.

Dr. Diana Zuckerman with the National Center for Health Research says 6,000 women have asked for  help getting insurance companies to pay for their implants to be removed.  Dr Zuckerman says they’ve only been able to help 1,000 women get their implants removed and of those only 25% were able to get insurance coverage.  

However, the results after explanting are dramatic. Of the 1,000 women, 90% reported their health improved with 61% saying there were “much better”.  

See the original story and video here.

Laurie McGinley, Washington Post: March 26, 2019.

Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding of the risks — which includes a rare cancer that is linked to several deaths around the world — posed by the devices.

The members, speaking at the conclusion of a two-day FDA hearing, signaled support for a standardized, easily understood consent form that would lay out the major risks of the devices and be reviewed by patients and their doctors before a woman underwent surgery.

They said the FDA could negotiate the format and content of the consent form with patients, plastic surgeons’ groups and manufacturers. Frank Lewis, chairman of the agency’s panel on general and plastic surgery devices, said the current documents written by manufacturers are too long — some are more than 70 pages — and unwieldy. “They were constructed to provide legal protection for the companies,” he said.

During the sometimes emotionally wrenching hearing on implants, several women testified that they had not been adequately warned of risks posed by implants and were harmed by the devices.

The FDA had asked the panel to hold the hearing and provide guidance on several complicated issues involving implants, which have stirred controversy for decades.

The panel members came up with other suggestions for the FDA. One said that the tissue removed when implants are taken out should be analyzed by pathologists to try to understand what caused any illness or complication. Another said it was important to try to establish an official definition for “breast implant illness” — the constellation of autoimmune problems that many women say are caused by implants — so that insurance would pay for treatment of the ailments. The FDA has said the weight of evidence does not support such “systemic” effects from implants.

But the panel did not appear to reach consensus on recommending that any implants be taken off the market, including certain textured ones that have been linked to cancer. Many patients and advocates called for such a ban, but several panel members said they opposed the step at this time.

At the end of the meeting, however, Texas plastic surgeon Pierre Chevray, a member of the panel, called for banning textured implants that have been barred in other countries.

The FDA has identified 457 cases and nine deaths in the United States associated with the cancer, called Breast Implant-Associated Anaplastic Large Cell Lymphoma. Six hundred cases and 17 deaths have been reported worldwide. Several countries have banned one type of textured devices.

Diana Zuckerman, a longtime advocate who is president of the National Center for Health Research, said the recommendations from the panel “were rather vague,” but she said the meeting was important because it allowed women to tell their stories to the FDA and the surgery panel. “We don’t know what comes next, but I’m hopeful,” she said after the meeting.

The panel also said that the FDA should change its recommendation that women with implants begin to get MRIs after three years to check for ruptures. Perhaps starting after six years would be more practical, considering the cost involved, members said.[…]

See the original story here.

Laurie McGinley, Washington Post: March 25, 2019.

Women who say they were harmed by breast implants demanded the Food and Drug Administration take new steps to protect consumers, including providing more information about potential risks and banning devices linked to the most serious complications, including cancer.

Telling searing stories about broken health, disrupted families and lost careers, the women pressed an FDA advisory panel to recommend more long-term research, bans or restrictions on certain products and a beefed-up informed consent process so that women have a clear understanding of the risks and benefits of the devices before they opt for surgery.

“I was not warned” about the risks of implants, Jamee Cook, an advocate and former ER paramedic, told the FDA’s expert committee. Cook, who lives near Dallas, said that after getting implants in 1998, she suffered for years from swollen lymph nodes, chronic fatigue, migraines and a low-grade fever. She said she eventually had the devices removed, after which many, but not all, of her symptoms eased.

The FDA said recently it is taking a closer look at implants, which have sparked anger and contention for decades. The agency asked its General and Plastic Surgery Devices Advisory Committee for recommendations on a raft of issues, and Cook’s testimony was part of a two-day hearing, which continues Tuesday, on the key issues.

Several plastic surgeons pleaded with the panel to proceed carefully, saying that implants generally are safe and an important option for women who want breast augmentation or reconstruction after breast cancer surgery. They said that women’s choices should not be curtailed. About 400,000 women a year get implants, 75 percent for cosmetic reasons and the rest for reconstruction after breast-cancer surgery.

Many of the dozens of patients who attended the meeting at FDA’s headquarters in Silver Spring, Md., wore ribbons to graphically state their concern about two types of illnesses they say are linked to implants. Black and white ribbons symbolized what’s now called “breast implant illness,” a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue. Pink and green ribbons signified an uncommon lymphoma that health authorities around the world, including the FDA, link to some implants.

Anastasia Allmendinger, a 53-year-old resident of Newport News, Va., said that she got implants in 2010 and years later was diagnosed with the cancer, called anaplastic large cell lymphoma, or ALCL. She underwent surgery to remove the implants, chemotherapy and a stem-cell transplant, and is now doing well, but said that manufacturers should be held accountable for the illnesses and women should be better informed. Experts say that many patients can be successfully treated only with surgery.

Many of the advocates who spoke on Monday called for a ban on textured implants — the kind most strongly linked to the cancer. There is some evidence the problem could be caused by bacterial infections involving the implants, researchers said.

The FDA has identified 457 cases of the lymphoma and nine deaths in the United States. Six hundred cases and 17 deaths have been reported worldwide.

On the other main illness of concern — the one linked to autoimmune and connective-tissue disease — the FDA and the patient community have long been at odds.

Thousands of women have complained about autoimmune and connective tissue problems on social media but the FDA has repeatedly said that the “weight of evidence” does not show implants cause “systemic” illness.

That opinion was challenged last September, when researchers at MD Anderson Cancer Center found that silicone implants were linked to higher rates of autoimmune disorders such as scleroderma and rheumatoid arthritis than found in the general population. A leading author, Mark Clemens, said the study didn’t prove cause and effect but signaled a reason for concern.

The FDA immediately expressed skepticism, saying the study was flawed. But Binita Ashar, the agency’s director of surgical devices at the FDA’s Center for Devices and Radiological Health, also said the agency is stepping up its long-term surveillance of implants and using patient registries to track complications from the devices.

That view was repeated in the agency’s announcement about the meeting that began Monday. The FDA said that “there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses.” But it added, “there are numerous breast implant patients convening on social media to discuss a wide variety of symptoms that they are experiencing – symptoms which may or may not meet the diagnostic criteria to be categorized as a disease.”

Diana Zuckerman, president of the National Center for Health Research, said in an interview she doesn’t understand “why the FDA seems so close-minded” about the scientific evidence that at least some women have developed autoimmune diseases as a result of their breast implants. “We have always said we don’t know what the percentage is — just that for women who are sick, getting them out makes them better,” she said.

Zuckerman presented data on Monday from a study that her group conducted involving more than 400 women who had their implants removed because they were having health problems. In the vast majority of cases, she said, the women’s health improved. The study has not been published yet. […]

See the original story here.